MEDICAL DEVICES Uncommon sensors


Dr Ben Hwang, CEO of Profusa – a leading company working on developing real-time biosensors that track aspects of our overall health status – explains what biosensors could mean for the future of clinical trials.


challenges. Recruiting subjects is difficult, time- consuming and expensive. Retaining them is even harder. Then there is the question of how studies are designed in order to yield the most useful data as quickly as possible, without taking potentially hazardous shortcuts. Biosensors could help overcome those hurdles


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by swiftly and efficiently putting biochemical data from human subjects into the hands of researchers, without the need for extensive clinical interaction. Our company, Profusa, has developed a tiny,


injectable biosensor that provides continuous, real-time monitoring of biochemical markers. These biosensors, which are relatively inexpensive


linical studies are the bedrock of drug development and medical device innovation, and yet they are fraught with


when deployed at scale, create data streams that don’t rely on in-clinic visits.


How the technology works Unlike conventional sensors made with a sensing electrode wire for glucose monitoring, the Profusa biosensor is made from a tissue-like hydrogel material that is constructed in a fashion that is benign to the body’s foreign body response. Consequently, it does not trigger the hyper- inflammation and scar tissue formation that commonly occurs with traditional sensors. With that advantage, the biosensor – small enough to be injected under the skin via a common hypodermic needle – can safely remain in the body for months or even years, as opposed to days. Its measurements, which come in the form of a fluorescent light signal, are read by a lightweight


68 | Outsourcing in Clinical Trials Handbook


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